A Prospective, Single-center, Phase II Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Newly Diagnosed Primary Plasma Cell Leukemia

What this Trial Is About

This research aims to evaluate the effectiveness and safety of a combination treatment using a VRD-based regimen Bortezomib, Lenalidomide, and Dexamethasone along with CAR-T cell therapy and autologous stem cell transplant in Chinese patients newly diagnosed with primary plasma cell leukemia. This prospective, single-arm, single-center phase II study focuses on this aggressive blood cancer to assess the treatments impact on disease control and patient outcomes. Participants first receive three cycles of induction therapy with the VRD regimen, followed by an initial infusion of CAR-T cells targeting BCMA. After this, they undergo three cycles of consolidation therapy with VR, then an autologous stem cell transplant ASCT, and a second CAR-T cell infusion. Maintenance therapy with lenalidomide or lenalidomide plus dexamethasone begins approximately 100 days after ASCT. Throughout the study, participants will be closely monitored through various assessments including response rates, safety and tolerability over two years, and progression-free survival at one year. Evaluations occur after induction therapy, after the first CAR-T infusion, at the end of consolidation, and six months after the second CAR-T infusion. Participants will also have laboratory tests and follow-up visits to track disease status and treatment side effects during the study period, which lasts several years.

A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia